# K043204: Sgarlato Labs Painfree Pump and Pain Control Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sgarlato Laboratories, Inc.
- Decided: Mar 30, 2005 after 132 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896422 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984146: Paragon Infusion, I-Flow Corp. (1999) Summary page 1.
- K990101: Pain Control Infusion Pump, Sgarlato Laboratories, Inc. (1999) Summary page 1.

## Indications for use
The Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.

Source page: https://510kreport.com/device/K043204
Methodology: https://510kreport.com/methodology